Identity
- Trade Name
- EXCELSIUS GPS FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- 2.5mm Hex Driver FDA UDI
- Model / Reference
- 6143.1827 FDA UDI
- Description
- 2.5mm Hex Driver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00193982192365 FDA UDI
- 510(k) Number
- K200047 FDA UDI
- FDA Product Code
- OLO FDA UDIHAW FDA UDI
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Robotic surgical arm system
Excelsius Gps by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical arm system.
- daVinci Xi — Intuitive Surgical, Inc. · Class II
- SHURUI Large Tissue Forceps — Beijing Surgerii Robotics Company Limited · Class IIb
- FLEX — Medrobotics Corporation · Class II
- Flex — Medrobotics Corporation · Class II
- Adapter, Bipolar Large Grasping Forceps, Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class I
- FLEX — Medrobotics Corporation · Class II
- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
Cleared under the same submission
K200047 also covers:
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
- EXCELSIUS GPS — GLOBUS MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Globus Medical, Inc.
Sources (1)
- FDA UDI 92288410-2441-46ac-9928-69500c778300 34 fields · synced May 30, 2026